Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

• Conditions: Cerebral Aneurysm; Arteriovenous Malformations

• Registration Number: NCT03306823
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.

Detailed Description

This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. This study is a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative activated coagulation time Changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. On the stage of randomized controlled study. This study is a multicenter, single-blind, prospective, randomized controlled study. Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-05-31
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-10
• Last Update Submitted: 2017-10-10
• Study First Posted: 2017-10-11
• Last Update Posted: 2017-10-11
• Primary Completion: 2020-09
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

1.All patients undergoing hybird surgery.

Exclusion Criteria

1. Poor general condition , severe primary disease, surgical contraindications
2. Patient or family refused surgery
3. Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
4. Combined with other hemorrhagic cerebrovascular disease
5. Combined with malignant brain tumor
6. Perinatal, Pregnancy
7. Patients unwilling to participate in the trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery	From the beginning of surgery to 48 hours after surgery	Hemorrhage event include intracranial hemorrhage caused by non-surgical reasons, as well as other organs or parts of the massive bleeding or small bleeding, Including subperitoneal hemorrhage, intraocular hemorrhage, gross hematuria, epistaxis time prolonged or repeated, gastrointestinal bleeding, hemoptysis, subconjunctival hemorrhage, hematoma greater than 5cm, bleeding difficult to control the and so on.

Secondary Outcome Measures

Name	Time	Method
Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery	From the beginning of surgery to 48 hours after surgery	Ischemia event include Cerebral infarction and transient ischemic attack.
Intraoperative blood loss	During the surgery	All the blood lost during the surgery should be collected and measured.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China